A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers
NCT ID: NCT05926609
Last Updated: 2023-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2023-07-27
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
SINGLE
Study Groups
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EB-PA
One capsule to be taken after breakfast once a day for 30 days
EB-PA
1 capsule to be taken after breakfast once a day
Placebo
One capsule to be taken after breakfast once a day for 30 days
Placebo
1 capsule to be taken after breakfast once a day
Interventions
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EB-PA
1 capsule to be taken after breakfast once a day
Placebo
1 capsule to be taken after breakfast once a day
Eligibility Criteria
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Inclusion Criteria
* Occasionally gym goer with a history of at least 1 month of training but not participating in the resistance-type activity for ≥3 months.
* Habitual non-veg eater
* Body mass index (BMI) 22 - 29.9 kg/ m2
* Waist Circumference 94-102 cm
* Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs before the exercise lab visit.
* Fasting blood Glucose ≤ 125 mg/ dl
* Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg
* TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L
Exclusion Criteria
* Presence of chronic disease
* Changes in body weight of more than 4.5 kg (10 pounds) in the past three months
* Individuals with uncontrolled hypertension
* Known cases of Type II Diabetes mellitus
* History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders
* Individuals who have any other disease or condition or are using any medication that, in the investigator's judgment would put them at unacceptable risk for participation in the study or may interfere with evaluations or non-compliance with treatment or visits
* Individuals who have been part of a clinical trial within 90 days before the screening
* Individuals who have used whey or other supplements anytime in the last 3 months
18 Years
35 Years
MALE
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Dr. Kumta Solanki's Clinic
Mumbai, Maharashtra, India
Dr. Preeti Bawaskar's Clinic
Thāne, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EB/230201/EB-PA/MMS
Identifier Type: -
Identifier Source: org_study_id
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